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RSS FeedPosted by Michael Wonder on 11 Jan 2017
U.S. FDA accepts biologics license application for Mylan and Biocon's proposed biosimilar trastuzumab
11 January 2017 - If approved, MYL-1401O has potential to be the first biosimilar trastuzumab in the U.S. ...
Posted by Michael Wonder on 11 Jan 2017
Merck receives FDA acceptance of supplemental biologics license application for Keytruda (pembrolizumab) in combination with chemotherapy for first-line treatment of metastatic non-squamous non-small cell lung cancer
10 January 2017 - Submission based on data from KEYNOTE-021 trial, cohort G, which enrolled patients regardless of PD-L1 expression. ...
Posted by Michael Wonder on 11 Jan 2017
ViraCyte granted U.S. FDA fast track designation for Viralym-C
10 January 2017 - ViraCyte today announced that the U.S. FDA has granted fast track designation for Viralym-C, ViraCyte’s T cell ...
Posted by Michael Wonder on 10 Jan 2017
Egalet receives FDA approval for Arymo ER (morphine sulphate) C-II, an extended release morphine product formulated with abuse deterrent properties for treatment of chronic pain
9 January 2017 - Egalet Corporation today announced that the U.S. FDA has approved Arymo ER (morphine sulphate) extended-release (ER) tablets ...
Posted by Michael Wonder on 09 Jan 2017
FDA grants Roche’s cancer immunotherapy Tecentriq (atezolizumab) priority review in additional type of advanced bladder cancer
9 January 2017 - Second priority review granted for Tecentriq in advanced bladder cancer. ...
Posted by Michael Wonder on 08 Jan 2017
Don’t thank big government for medical breakthroughs
5 January 2017 - New cures come from private research, not cash dumped into the National Institutes of Health. ...
Posted by Michael Wonder on 06 Jan 2017
2016 financial year report from the Director
5 January 2017 - This letter is the Director's first annual report to various stakeholders. It summarises what Center have ...
Posted by Michael Wonder on 06 Jan 2017
Melinta Therapeutics’ new drug application for Baxdela accepted for filing by US FDA
5 January 2017 - Melinta Therapeutics announced today the U.S. FDA has accepted the company’s new drug applications for IV ...
Posted by Michael Wonder on 06 Jan 2017
FDA approves Genentech’s Lucentis (ranibizumab) for myopic choroidal neovascularisation
5 January 2017 - Granted priority review by the FDA. ...
Posted by Michael Wonder on 05 Jan 2017
Fibrocell announces FDA fast track designation of FCX-007 for treatment of recessive dystrophic epidermolysis bullosa
5 January 2017 - Fibrocell Science today announced that the U. S. FDA has granted fast track designation to FCX-007, the ...
Posted by Michael Wonder on 05 Jan 2017
New FDA drug approvals: breaking down the numbers
4 January 2017 - If a decline in FDA approvals of new pharmaceuticals is a bad sign for the industry, ...
Posted by Michael Wonder on 05 Jan 2017
New “21st Century Cures” legislation: speed and ease versus science
5 January 2017 - The 21st Century Cures Act was signed into law in December 2016. Praised by its advocates as ...
Posted by Michael Wonder on 05 Jan 2017
Neurelis intra-nasal diazepam treatment for epilepsy granted fast track designation by FDA
4 January 2017 - Neurelis today announced that the US FDA has designated NRL-1 (intranasal diazepam) as a fast track development ...
Posted by Michael Wonder on 05 Jan 2017
FDA grants fast track designation to Enanta's FXR agonist candidate EDP-305 for the treatment of NASH with liver fibrosis
4 January 2017 - Enanta Pharmaceuticals today announced that the U.S. FDA has granted Enanta’s drug candidate EDP-305, an FXR agonist, ...
Posted by Michael Wonder on 04 Jan 2017
A review of CDER’s novel drug approvals for 2016
4 January 2017 - This past year was another successful year for the new drugs program in FDA’s Center for Drug ...